(Senior) Regulatory Affairs Manager (m/f/d) - Clinical Business

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(Senior) Regulatory Affairs Manager (m/f/d) - Clinical Business, Hamburg

Client:

EVIDENT Europe GmbH

Location:

Hamburg, Germany

Job Category:

Other

EU work permit required:

Yes

Job Reference:

d4a7bbf2eff9

Job Views:

8

Posted:

25.06.2025

Expiry Date:

09.08.2025

Job Description:

Company Overview:
Headquartered in Tokyo, Japan, Evident employs around 4,500 people across 57 locations worldwide. Its European branch, headquartered in Hamburg, employs approximately 770 people in 16 countries. The product portfolio includes microscope systems used in clinical diagnostics, research, and industrial applications, along with videoscopes and non-destructive testing products.

Position Summary:
As a (Senior) Regulatory Affairs Manager (m/f/d) - Clinical Business, you will oversee strategic and operational regulatory support for digital pathology systems. You will liaise between Regulatory Affairs, Clinical Affairs, Product Development, and Software Development, supporting product lifecycle management.

Responsibilities:

• Develop and implement regulatory strategies for digital pathology products.
• Manage and submit regulatory filings (e.g., MDR, IVDR, FDA 510(k), Health Canada, PMDA).
• Prepare and maintain technical documentation per MDR/IVDR and ISO 13485 standards.
• Support clinical evaluations and develop clinical data strategies.
• Assist software development projects with regulatory requirements (IEC 62304, ISO 14971, SaMD).
• Coordinate with external partners, notified bodies, and regulatory authorities.
• Participate in audits and inspections.
• Train and advise internal teams on regulatory topics.

Requirements:

• Degree in a scientific, technical, or medical field (e.g., Biology, Medical Engineering, Regulatory Affairs, Medical Informatics).
• Minimum 5 years of experience in Regulatory Affairs for medical devices, preferably digital or imaging systems.
• Deep understanding of European (MDR), US (FDA), and other relevant regulations.
• Experience with SaMD, IEC 62304, ISO 14971, GxP, and data integrity.
• Knowledge of clinical evaluations and studies (e.g., MDCG guidelines).
• Excellent communication and teamwork skills, structured and solution-oriented approach.
• Fluent in English and German (spoken and written).

Benefits:

• Flexible working hours, including remote work options.
• 30 days of annual leave.
• 13.5 salaries per year.
• Regular training opportunities.
• Extensive pension scheme.
• Employee savings plan contributions.
• Preventive healthcare, free beverages, and fresh fruits daily.
• Company events and activities.
• Dynamic and international work environment.

Evident Europe GmbH is an equal opportunity employer and welcomes applications.